“Ms Malfortuna is a 60-year-old white female with a recent history of significant depressive symptoms, including insomnia, poor appetite, decreased energy, anhedonia, and lack of motivation. She has been in psychotherapy with me for 3 months, but has made little progress, and is now requesting medication. According to her primary care doctor, Dr Basanizo, Ms M has a medical history of early-stage breast cancer, operated on 1 year ago, and is now in a stable remission with no signs of recurrence. She is maintained on chemotherapy (tamoxifen [Nolvidex] 20 mg/day), which Dr B. says she is tolerating well. Ms M. also has a skin infection, for which a dermatologist, Dr Pelle, has prescribed linezolid [Zyvox] 600 mg bid, without reported side effects. I called Dr Basanizo, and he saw no contraindications to an antidepressant trial. Since he was rushing to see his next patient, we did not discuss specific meds. However, Ms M tells me she had a similar bout of depression 5 years ago, and had good results with fluoxetine, without significant side effects. Accordingly, I will give her Rx for fluoxetine 20 mg daily, and see her back here in 1 week. –R.X. Sciolus, PhD, Medical Psychologist

This scenario could easily be played out in the state of Oregon, unless Governor Kulongoski uses his veto pen before April 8. Otherwise, Oregon will become the third state in the country – along with New Mexico and Louisiana – to grant “prescribing privileges” to specially-trained psychologists.1,2 Although the Oregon legislation does require the prescribing psychologist to “. . . maintain an ongoing collaboration with the health care professional who oversees a patient's medical care…”2 it is not clear that the “health care professional” will be a physician who actually monitors and approves the prescriptions written by the psychologist. There is also no requirement that the prescribing psychologists obtain consultation with a psychiatrist; nor are there any restrictions placed on the age, medical comorbidity, or diagnoses of the patients treated by the psychologists.

For the moment, let’s leave Ms Malfortuna and simply note that the prevalence of undetected metabolic, cardiac, and neurological disease among “psychiatric” patients is disturbingly high—- particularly among inpatients and the elderly.3 Let us also note that there are as many as 7000 deaths annually in the US from adverse drug reactions.4 Finally, let’s also briefly acknowledge the tricky medicolegal issues raised by this legislation; for example, would "prescribing psychologists" be willing to assume full medico-legal responsibility for any adverse drug reactions incurred by their "patients"? Would they be willing and able to manage that well-known, gut-wrenching call at 3 AM, in which the patient is complaining of a sudden, unexpected side effect of a psychotropic medication? Psychiatrists, of course, routinely handle such calls, and accept the medical and legal responsibility of doing so. Are physicians also ready to assume the substantial medicolegal risks of “collaborating” with a “prescribing psychologist?”

There is a notion among some non-medical professionals—-and, alas, also among some physicians—-that psychopharmacology is really “no big deal.” Anxiety? You get some buspirone, or maybe a short course of a benzodiazepine. Depression? You get an SSRI. Mania or psychosis?—-send the patient to the emergency room. Side effects and drug interactions? No problem! Just turn on your PDA and see what the drug interaction software says. Fortunately—-with a few notable exceptions—-most commonly-prescribed psychiatric medications are not highly toxic, when taken as prescribed, and under “ideal conditions”; for example, when the patient has no underlying major medical illnesses; takes no concurrently prescribed interacting medications; is not prescribed new medications by another clinician, takes no over-the-counter agents like St John’s Wort, etc. Unfortunately, the “real world” rarely produces ideal conditions. As a psychopharmacology consultant, I spent much of the last 25 years picking up the pieces for some physicians who thought that pharmacotherapy was “no big deal.”

The notion that the medical skills required to master pharmacotherapy can be acquired without extensive medical training is, in my view, both unproven and potentially dangerous to the general public. Generalizations based on the apparently competent performance of a hand-full of psychologists, trained under very carefully-controlled conditions--ie, in the Department of Defense training program5--are not by themselves reassuring. We would need to evaluate several hundred psychologists (and a few thousand patients) over several years, with careful attention to the kinds of patients treated; how many of these patients had co-morbid medical illnesses; how many received multiple medications; etc. To my knowledge, we do not have such data. Until we do, allowing specially-trained psychologists to practice medicine—- for that is what the euphemism “prescribing privileges” deftly conceals—- constitutes a foolish and potentially dangerous decision.6,7

This is not to say that physicians in general or psychiatrists in particular have practiced exemplary pharmacotherapy. As a consultant, I can still remember wondering, in a few instances, whether the referring physician ought to have “prescribing privileges”! Unwarranted polypharmacy, as well as both over- and under-prescription of psychotropics, are all too common. And, yes—I certainly made my share of mistakes along the way, too.

Oh—-but what of our patient, Ms Malfortuna? Alas, she will be lucky to survive her encounter with the “prescribing psychologist,” Dr Sciolus, who has “collaborated” with the very harried PCP, Dr Basanizo. To begin with, the linezolid Ms M. is taking for her skin infection is a nonselective inhibitor of monoamine oxidase; the interaction of an MAOI and the SSRI, fluoxetine, can provoke a severe and potentially lethal serotonin syndrome.8 Then there is the matter of Ms M’s cancer chemotherapy. Fluoxetine is a strong inhibitor of the cytochrome P450 2D6 system (CYP 2D6), which is required to convert tamoxifen to a pharmacologically active drug.9 Unless this error is caught, the patient’s chemotherapy could soon be rendered ineffective.

The case of Ms Malfortuna was meant to illustrate the potential hazards of uninformed prescription of psychotropics; and the inadequacy of poorly-structured “collaboration” between non-physician prescribers and physicians. But wait: as my Tufts and Psychiatric Times colleague Daniel Carlat, MD pointed out to me (personal communication, 3/25/10) a “prescribing psychologist” with access to a good drug-interaction program could easily have checked for the relevant drug interactions in this case and thereby avoided “misfortune.” Point taken—-but are psychiatric physicians really no more than the sum of the data contained in a PDA or the PDR?

Let’s look at another composite case, based on several patients I have evaluated as a consultant:

Mr Senex is a 70-year-old widower who developed a severe, agitated depression after the mortgage on his house was foreclosed. He was in treatment with R.X. Sciolus, PhD, who provided cognitive-behavioral therapy to Mr Senex for 2 months, with only modest improvement in the patient’s depression. Symptoms included poor concentration, severe psychomotor agitation, 15-lb weight loss, anhedonia, and suicidal ideation. Dr Sciolus checked with Mr Senex’s PCP, who reported that the patient was in good health, with no active disease processes or abnormalities on recent laboratory testing. Accordingly, Dr Sciolus began Mr. Senex on paroxetine 10 mg daily, following recommendations for geriatric dosing of this agent. After 2 weeks of treatment, Mr Senex showed no improvement in his depressive symptoms, and Dr Sciolus increased the paroxetine to 20 mg/day. After another week, the patient’s psychomotor agitation appeared worse, and he voiced the view that, “Maybe I’d be better off dead...I feel like I’m crawling out of my skin.” Alarmed by this, Dr Sciolus increased the paroxetine dose to 30 mg/day. The patient reported slight improvement in his mood, but also complained of urinary retention and feeling like, “I’ve got ants crawling inside my legs.” At this point, Dr Sciolus sent Mr Senex for an evaluation with the patient’s PCP, Dr Swampt. After a brief examination, Dr Swampt determined that the patient’s urinary retention was probably due to the anticholinergic effects of the paroxetine, and that the patient’s psychomotor agitation and “antsy” feeling was probably SSRI-induced akathisia. Dr Swampt recommended a reduction in the paroxetine dose (to 20 mg) and added a small dose of the beta blocker, propranolol (20 mg po bid) for the akathisia. Mr Senex reported feeling less “antsy” within 2 days, and his urinary retention abated.

However, within another week, Dr Sciolus noted a change in the patient’s mental status; Mr Senex seemed confused, disoriented, and was unable to recall 3 items after 2 minutes. Dr Sciolus called Dr Swampt, who hypothesized that the anticholinergic effects of the paroxetine might be causing the change in mental status; he suggested to Dr Sciolus that switching to a less anticholinergic SSRI, such as citalopram, might be the best approach. However, the next day, the patient wound up in the emergency room, having been brought there by his son. In the ER, the patient was disoriented, confused, and unable to perform simple calculations. Laboratory studies in the ER revealed hyponatremia (Na+ = 118 mEq/L, nl =135-145), decreased plasma osmolality, and abnormally increased urine osmolality. SIADH (Syndrome of Inappropriate ADH Secretion) was diagnosed, most likely related to the use of paroxetine. (By the way: since paroxetine has “non-linear” pharmacokinetics, doubling the dose may result in a disproportionately large increase in plasma drug levels).10

The case of Mr Senex is hypothetical, and aimed at showing that the “easy” medications in psychopharmacology—-the so-called SSRIs—-are occasionally anything but easy. Antipsychotics or lithium? Don’t even ask. The case also makes the point that a clinician without adequate medical and neurological training is at a substantial disadvantage when it comes to recognizing the nature of certain medical problems, such as akathisia. Akathisia is not commonly-seen with SSRIs, but accounts for perhaps 45% of SSRI-induced extrapyamidal side effects.11 Akathisia is associated with suicidal ideation, and—-even for skilled physicians--may be difficult to distinguish from worsening psychomotor agitation secondary to primary depressive illness. SIADH due to SSRI use may be quite common, and is seen in as many as 12 % of elderly patients, usually within the first few weeks of treatment.12-14

The case of Mr Senex raises the question: does the “prescribing psychologist-collaborating physician” model represent the safest and most cost-effective mental health care system? Would not Mr. Senex have been better served, had Dr Swampt prescribed the SSRI in the first place—ideally, in consultation with a geriatric psychiatrist? To be sure, such consultation is simply not available or feasible in many parts of the country—-but “telepsychiatry” is becoming increasingly available as a means of connecting primary care doctors with outside psychiatric experts.15 Such “virtual” consultation might well have spared Mr Senex some unpleasant and potentially dangerous side effects.

In making my case against “prescribing psychologists,” I don’t want to diminish in any way the enormous contributions to mental health care on the part of psychologists, social workers, nurses, and other professionals. Neither do I necessarily want to apply these arguments to all non-MD “prescribers”--such as clinical nurse specialists working in direct consultation with a psychiatric physician. But let’s be clear: psychotropic medication is not a “set and forget” pill. Pharmacotherapy is a week-by week, day-by-day process of careful monitoring—-not only for potential side effects, but for the effects of concurrent medical illness; infection; changes in the patient’s kidney or liver function; changes in sleep, weight, and appetite; effects of newly-introduced antibiotics or heart medication; and a myriad of other medical factors that pour in to one’s office, every day. It is not enough to say to the patient, “Well, if you have any problems with this medication, go see your primary care doctor.” (When I was actively seeing patients, I had my blood pressure cuff and stethoscope always handy, and would often do circumscribed neurological examinations to check for medication side effects).

[The] art is long, life is short; opportunity fleeting, experiment dangerous, judgment difficult. And the notion that we will improve patient care by extending the practice of medicine to those without adequate medical training is, indeed, “Fool’s Gold.” 7

************ Acknowledgments: I would like to thank John Grohol, PsyD, and Daniel J. Carlat MD, for allowing me to voice some of these concerns on their blog sites: psychcentral.com and http://carlatpsychiatry.blogspot.com/ respectively. I also want to thank Thomas Hansen MD, for providing me with useful references and comments; and Daniel Carlat MD for providing constructive critical feedback on an early draft. The views expressed here, however, are solely my own. ************

It's difficult to answer Dr. Huff's "war stories" approach to this issue, as I simply don't accept the notion that these colorful and troubling anecdotes are a scientific measure of the average psychiatrist's competence or professionalism. Of course, one can find evidence of dissatisfaction among patients, with regard to their treatment by internists, surgeons, and--I would wager--psychologists. But even if the level of practice among psychiatrists is not always what I would wish (true enough!), that is hardly an argument for extending medical practice ("prescribing") to those without adequate medical training. It's a bit like arguing, "There was a bridge collapse in our city, and that bridge was built by professional engineers. This shows that we might as well have our next bridge built by grad students in engineering!"

I also disagree with Dr. Huff's premise that it is my job, as a physician, to "prove" that so-called prescribing psychologists have made poor decisions or errors.

On the contrary: in my view, it is your responsibility, Dr. Huff, as a psychologist, to provide the general public and health care authorities the requisite scientific data showing that your "prescribing" colleagues are practicing safe and effective psychopharmacology. As I will indicate in my response to Dr. Mishler [to follow tomorrow], data from the Dept. of Defense program are not directly applicable to psychologists prescribing in New Mexico and Louisiana.

Furthermore, the absence of evidence is not "evidence of absence." The mere absence of adverse reports is not scientific evidence of safe practice, and is notoriously susceptible to whims of reporting, vested interests in concealing adverse reactions, apathy on the part of "collaborating" physicians, fear of malpractice suits, etc. If we applied the same "let's wait for bad reports to trickle in" logic to the safety of medications marketed for medical illnesses, the public outrage would well up like a tsunami!

Incidentally, as someone who has both a sibling and a cousin who are psychologists--and who had wonderful psychologist mentors during residency--I have no vested interest in antagonizing my psychologist colleagues! Nor do I worry about "competing" with psychologists, as I am no longer actively seeing patients.

Rather, for me, it is a matter of science and the public safety to insist that the burden of proof must rest with those who assert medical prerogatives but who omit the time and training required by physicians (or, for that matter, required by clinical nurse specialists, with whom I have collaborated very productively.).

Finally, I do thank Dr. Huff for his kind remarks on my lectures. And, I will add that I often find the reports of neuropsychologists to be extremely useful; indeed, I believe both psychologists and neuropsychologists contribute a great deal to the care and treatment of many patients treated by psychiatrists.

DR PIES REPLIES TO DR MISHLER AND MR MORRIS-OSTROM:I appreciate Dr. Mishler’s frank critique of my editorial; however, a careful reading of what I actually said will show that Dr. Mishler has attributed views to me that I neither state nor hold. First of all—as one who received invaluable training from psychologists during my residency—I have the utmost respect for psychologists, and in no way suggested that psychologists would be “reckless” or prone to “shirk responsibility.” In my first case vignette—that of Ms. Malfortuna—the “prescribing psychologist” made a good-faith attempt to discuss the patient’s medical condition with the patient’s primary care doctor, who (quite realistically, I believe) was very rushed at the time and did not discuss the case adequately with the psychologist. The errors in that case—failing to recognize two admittedly subtle adverse drug-interactions—could still have occurred if a primary care physician or even a psychiatrist had been caring for the patient. (Indeed, I heard from one experienced psychopharmacologist who was not aware that the anti-microbial, linezolid, was a monoamine oxidase inhibitor). The point of the vignette was not to cast aspersions on psychologists, or to show that “prescribing psychologists” would be uniquely susceptible to errors; but rather, to show that the stakes in “prescribing” are very, very high—indeed, they are sometimes a matter of life and death. If saying so amounts to inspiring “fear”, as Dr. Mishler implies, then I shall have to plead guilty.

The second of my case vignettes involved a complicated set of medical problems, including one endocrine disorder (SIADH due to an antidepressant) and a neurological disorder (akathisia). While I am pleased that Dr. Mishler’s masters-level course used my psychopharmacology Handbook, neither that text nor any psychopharmacology text would adequately equip a psychologist to diagnose endocrine or neurological disorders, or to take appropriate medication management steps in light of such disorders. (Incidentally, by way of disclosure: I have no doubt whatsoever that I could sell a great many more of my psychopharmacology textbooks if the pool of “prescribers” included psychologists—I guess I’ll just have write the Great American Novel!).

The art and science of medicine is more than the study of drug interactions and pharmacokinetics—it is a comprehensive understanding of how these issues are affected by, and impinge upon, the function and dysfunction of the brain, heart, liver, kidneys, pancreas, and skin, in both health and disease. It is not a matter of one’s willingness to assume medical-legal responsibility, as Dr. Mishler seems to assume—it is a matter of whether one has the training to do so. My position is that trying to tease out “prescribing” from the art and science of general medicine is like trying to separate skin from bone, using a paring knife—it can’t be done without injury to the patient.

Dr. Mishler asserts that my characterization of prescribing psychologists “is not based on evidence.” Specifically, Dr. Mishler asserts that “…the records show the psychologists are safely prescribing…” and that “…there are no reports of harm at the hands of prescribing psychologists, not in New Mexico, not in Louisiana and not in the DoD program.” First: let’s be clear that the DoD program was not remotely comparable to the psychologist prescribing systems set up in New Mexico or Louisiana. In the DoD program, a minuscule number of psychologists—ten—were methodically and intensively monitored and supervised by clinical psychiatrists. This is certainly not the case in either New Mexico or Louisiana. Moreover, a study of the DoD program by the American College of Neuropsychopharmacology (ACNP) revealed that while the psychologists performed very well,

“… the majority of psychologists trained by the DoD to prescribe medications treated patients in outpatient clinics rather than hospitals. The majority of patients treated in these settings were diagnosed with adjustment disorders, anxiety disorders or depressive disorders. Only one trainee treated patients with more serious or acute psychiatric conditions in an inpatient setting.” (from NAMI website)

“…Even though the DoD curriculum was scaled back after year one, it still required significantly more academic training and clinical training and supervision than the New Mexico law requires. For example, the DoD curriculum required 660 hours of academic training versus 450 for the New Mexico curriculum. Additionally, the DoD curriculum required approximately 1,900 hours of clinical training versus a minimum of 400 hours to be granted conditional certification in New Mexico.”

Not incidentally: the proposed Oregon statute, as I read it, does not even require that the “prescribing psychologist” collaborate with a physician; but rather, with “…the health care professional who oversees a patient's medical care”. Does this mean a physician? A nurse practitioner? A physician’s assistant? The wording clearly does not require any collaboration at all with a psychiatrist, unlike in the DoD program.

Thus, it is not possible to extrapolate from the DoD study to the “natural” conditions faced by psychologists in New Mexico or Louisiana; nor is it scientifically defensible to apply the DoD safety data to the “real-world” of clinical practice in those states. To my knowledge—and if Dr. Mishler has seen “records” or published data to the contrary, I’d welcome the references—there has been no systematic evaluation of prescribing patterns and clinical outcomes among patients medicated by psychologists in these states—none. I do not subscribe to the view—evidently endorsed by Dr. Mishler—that “absence of evidence is evidence of absence.” That is, I do not believe it is scientifically defensible to assert that if there are no reports of death or serious injury among patients medicated by psychologists in these two states, we are therefore entitled to conclude that the psychologists have performed safely and competently. Let me add that such might well be the case—we simply do not know. But relying solely on incoming reports from patients, psychologists, or physicians is not a scientific method of assessing risk.

We would need comprehensive tracking data, concerning the kinds of prescriptions written by these psychologists; whether the prescribed agent was appropriate to the diagnosis; whether the dosing was appropriate; whether co-morbid or underlying medical conditions had been ruled out or considered; whether the prescribing psychologist had adequate consultation with a physician, etc. None of this means I consider the psychologists in these states “dangerous prescribers”, as Dr. Mishler mistakenly infers from my editorial. On the contrary, I would guess that the majority have practiced responsibly and competently—but this misses the point: the general public and the scientific community should not have to “guess” about such a critical issue. We need the actual research.

I suspect that if we were discussing an ingestible product, instead of a service, Dr. Mishler and others (including some psychiatrists) would take a very different position on the matter of what counts as “evidence” of safety. That is, if a drug company produced a new antidepressant, and asserted, in defense of the drug’s safety, “Well, so far, we haven’t gotten any adverse reports back from any patients or doctors,” I would expect the company to be the target of professional ire, consumer outrage, and legal sanctions by the U.S. Food and Drug Administration.

Nor do I buy the notion that the burden of proof rests upon those who caution against extending medical practice to psychologists—for that is what “prescribing” entails. On the contrary: following the dictum, “First, do no harm,” the burden of proof rests firmly on those who would assert the right to practice medicine, having spared themselves the time and inconvenience of standard medical training. When I see such evidence, I may indeed reconsider my position.

Finally, with respect to psychology doctoral candidate Randall L Morris-Ostrom: I appreciate your referring me to the American Psychological Association Recommended Postdoctoral Education and Training Program In Psychopharmacology for Prescriptive Authority. This is indeed a remarkable document, and worth the time of any physician interested in these matters. My first response to the incredibly ambitious curriculum was to think, “My goodness—this sounds remarkably like medical school!” I was astounded to find that among the “clinical competencies that may be associated with the domain of instruction” was coursework in physical examination and “Laboratory and Radiological Assessment”! Furthermore, this coursework is intended to be integrated with “…supervised clinical experience or lab experience in conducting physical exam, ordering psychometric and laboratory tests, understanding results and interpretation.” Indeed, Mr. Morris-Ostrom: if such a curriculum were actually put in place, and required by law for all “prescribing psychologists”, my concerns and misgivings would be greatly allayed. But these are merely theoretical proposals—and I have yet to see any of them written into the laws of Oregon or any other state now granting “prescribing privileges” to psychologists. Indeed, the comprehensive nature of these training proposals does not diminish my belief in the necessity of a thorough medical education, Mr. Morris-Ostrom—it strengthens it.